Table 2.
Emerging wound care treatments and wound dressings/devices for hidradenitis
| Treatment(s) | Author or clinical trial no. (ClinicalTrials.gov identifier) | Study type | Study goal and primary endpoint(s) | No. of patients enrolled | (Anticipated) completion date | Results or recruitment status |
|---|---|---|---|---|---|---|
| General wound care topicals and dressings | ||||||
| Antibiofilm surfactant wound gel | NCT04648631 | Open label trial |
Examine changes in the microbiome of HS tunneling wounds after treatment Endpoint: change in microbiome as measured by quantitative 16S ribosomal DNA PCR for bacterial enumeration from punch biopsy samples at baseline and week 4 |
15 | July 2022 | Completed |
| Wound bed preparation and exudate management dressings (Cutimed Sorbact Hydroactive B, [ABIGO Medical AB, Askim, Sweden], Cutimed Siltec, and Cutimed Sorbion Sana Multi-Star [both BSN medical Inc., Charlotte, North Carolina, USA]) | Schneider et al. 2022 [65] | Open label trial |
Determine how different wound dressings affect QOL for people with HS Endpoint: DLQI scores at 6 weeks versus baseline |
28 | March 2021 | Decrease of DLQI score from a median of 15.5 at baseline to 12.5 at week 6 (p = 0.0048) |
| HidraWear AX Dressing (HidraMed Solutions, Galway, Ireland) | Moloney et al. 2022 [3] | Open label trial |
Determine ease of use of HidraWear dressings compared to existing product/dressing us as well as improvement on QOL and comfort Endpoint: change in QOL as measured by DLQI at 3 weeks and VAS pain score at day 21 versus day 0 |
15 | October 2020 | Significant improvement in dressing-related pain (p < 0.001) and DLQI score (19.3–4.5, p < 0.001) at week 3 |
| Post-operative wound care | ||||||
| Biodegradable temporizing matrix (BTM) | NCT05477225 | Phase 4 randomized, controlled, comparative study |
Compare the efficacy of NovaSorb® BTM (PolyNovo, Port Melbourne, Australia) and human cadaveric allograft Endpoint: mean days to wound coverage with split skin graft after excision of HS between wounds treated with either BTM or the allograft |
10 | July 2024 | Recruiting |
| Bioelectric dressing (Procellera™; Vomaris Innovations Inc., Tempe, AZ, USA) | NCT05057429 | Randomized contralaterally-controlled, within-person design open-label trial |
Determine if a bioelectric dressing is more efficacious for wound healing after de-roofing compared to a standard gauze dressing with petroleum jelly Endpoint: healing rate of post-surgical wounds reported as the area reduction in cm2/per day up to 8 weeks |
12 | March 2024 | Recruiting |
| OFM (Endoform™; AROA Biosurgery, Auckland, New Zealand) | NCT04354012 | Open label trial |
Monitor time and outcome of healing of wounds associated with HS using combination dressing of OFM (Endoform™), Hydrofera Blue (methylene blue and gentian violet), and Hypafix tape Endpoint: wound healing time and percentage of wound healing up to week 8 |
5 | December 2023 | Not yet recruiting |
| OFM sheet graft and morelized extracellular matrix (Myriad Matrix™ and Myriad Morcells™) (AROA Biosurgery) | NCT05243966 | Phase IV observational patient registry study |
Evaluate the safety and clinical outcomes of OFM (Myriad™) in soft tissue reconstruction procedures Endpoint: proportion of patients with TEAEs during 3 years |
300 | January 2026 | Recruiting |
| Petrolatum with non-stick bandaging | NCT05194969 | Randomized, triple-blinded trial |
Compare wet-to-dry versus petrolatum and non-stick dressing for second intention healing following HS surgery Endpoints: change in wound QOL survey score, change in pressure ulcer scale for healing score, and change in pain with dressing changes measured at 1, 2, 4, and 6 weeks post-surgery |
80 | April 2023 | Recruiting |
BTM Biodegradable temporizing matrix, OFM ovine forestomach matrix QOL quality of life, TEAE treatment emergent adverse events